CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2021/04/032810 [Registered on: 13/04/2021] Trial Registered Prospectively

Last Modified On:

13/04/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

To study the effectiveness of virechana(purgation therapy)in Hypothyroidism.

Scientific Title of Study

An open label single arm clinical study to evaluate the effectiveness of virechana karma in Hypothyroidism.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Geetismita Boruah
Designation	PG Scholar,Dept. of Panchakarma
Affiliation	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan
Address	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan,Department of Panchakarma, Room No-5, BM road,Thanirruhalla-573201,Hassan,Karnataka Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan,Department of Panchakarma, Room No-5, BMroad,Thanirruhalla-573201,Hassan,Karnataka Hassan KARNATAKA 573201 India
Phone	8638047447
Fax
Email	pg19150@sdmcahhassan.org

Details of Contact Person
Scientific Query

Name	Dr Ashvini Kumar M
Designation	Professor and HOD,Dept. of Panchakarma
Affiliation	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan
Address	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan,Department of Panchakarma, Room No-5, BMroad,Thanirruhalla-573201,Hassan,Karnataka Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan,Department of Panchakarma, Room No-5, BMroad,Thanirruhalla-573201,Hassan,Karnataka Hassan KARNATAKA 573201 India
Phone	8638047447
Fax
Email	ashvinipanchakarma@gmail.com

Details of Contact Person
Public Query

Name	Dr Ashvini Kumar M
Designation	Professor and HOD,Dept. of Panchakarma
Affiliation	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan
Address	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan,Department of Panchakarma, Room no-5 BM road,Thanirruhalla-573201,Hassan,Karnataka Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan,Department of Panchakarma, Room No-5 BMroad,Thanirruhalla-573201,Hassan,Karnataka Hassan KARNATAKA 573201 India
Phone	8638047447
Fax
Email	ashvinipanchakarma@gmail.com

Source of Monetary or Material Support

Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan BM Road,Thanniruhalla,Hassan-573201,Karnataka,India

Primary Sponsor

Name	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan
Address	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan BM Road,Thanniruhalla,Hassan-573201,Karnataka,India
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Geetismita Boruah	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan	Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan,Department of Panchakarma, OPD No-5,BMroad,Thanirruhalla-573201,Hassan,Karnataka Hassan KARNATAKA	8638047447 pg19150@sdmcahhassan.org

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee,Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital,Hassan,	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E039\|\|Hypothyroidism, unspecified. Ayurveda Condition: HYPOTHYROIDISM,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Not Applicable	Not Applicable
Intervention	Virechana with avipattikar churna 25 gms with honey	30 diagnosed subjects of Hypothyroidsm will be selected based on inclusion and exclusion criteria and will be first intervened with deepana pachana then snehapana(internal oleation)followed by virechana with avipattikara churna 25gms with honey.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1)Subjects who are diagnosed with hypothyroidism with or without oral thyroxin therapy. 2) Subjects fit for virechana karma. 3) Those subjects who are willing to participate in the study and are ready to sign the consent form. 4) Age of the subject should be between (18-60) years. 5) Inclusion of subjects in the study will be done irrespective of gender.

ExclusionCriteria

Details

1)Patients who have undergone any type of thyroid surgery.
2) Patients suffering from congenital hypothyroidism, drug induced hypothyroidism, progressive case of myxoedema, secondary hypothyroidism.
3) Systemic diseases like ischemic heart disease, renal impairment and hepatic impairment.
4) Hypothyroidism in pregnancy and during lactation.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Assessment of objective parameters was based on the changes in laboratory parameters like thyroid profile(serum T3,serumT4, serum TSH) on 1st day and 15 days after samsarjan karma.	3 years

Secondary Outcome

Outcome	TimePoints
Assessment of subjective parameters will be done with the help of a suitable clinical scoring of hypothyroidism-â€˜BILLEWICZ SCORE30â€™ on 1st day and 15days after samsarjan karma.	3 years

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

15/04/2021

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="1"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is an open label single arm clinical study to understand the effectiveness of virechana in Hpothyroidism.The subject will be intervened as follows-

1.Rookshana Karma (1^st- 3^rd)day Bahya rookshana,udwartana with triphala churna, abhyantara rookshanaa(deepana pachana with chitrakadi vati 500gms and panchakol phanta 100ml) until samyak rookshana lakshanas appear.

2.Snehapana with varanadi ghrita in arohana matra (4th- 10^th) day or till Samyak Snigdha lakshanas appears.

3)Vishrama kala after Samyak Snigdha lakshanas (11^th-13^th) day for 3 days.Abhyanga with moorchita tila taila followed by baspa sweda.

4)Virechana karma with avipattikar churna 25gms anupan â€“madhu on14^th day .

5.Samsarjana krama-(15^th -21^th) day based on the shuddhi attained.

6.Shaman ausadhi kanchnara guggulu 1gm twice daily to be administered for 15 days after completion of samsarjan karma.

ASSESMENT CRITERIA:

PRIMARY OUTCOME MEASURE: Assessment of objective parameters was based on the changes in laboratory parameters like thyroid profile(serum T3,serumT4, serum TSH) on 1^st day and 15 days after samsarjan karma.

SECONDARY OUTCOME MEASURE: Assessment of subjective parameters will be done with the help of a suitable clinical scoring of hypothyroidism-â€˜BILLEWICZ SCOREâ€™ on 1^st day and 15days after samsarjan karma.